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The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT01971593
Recruitment Status : Terminated (Investigator left institution)
First Posted : October 29, 2013
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ari Cedars, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Tetralogy of Fallot
Transposition of the Great Vessels With an Arterial Switch
Single Ventricle With a Fontan Palliation
Intervention Drug: Eplerenone
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eplerenone After Drug Free Period Eplerenone Before Drug Free Period
Hide Arm/Group Description

Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period

Eplerenone

Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period

Eplerenone

Period Title: Overall Study
Started 14 12
Completed 9 8
Not Completed 5 4
Arm/Group Title Total Study Group
Hide Arm/Group Description Crossover study, all patients pooled for baseline analysis
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
9
  34.6%
Male
17
  65.4%
Tetralogy of Fallot  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
12
  46.2%
Patients with Transposition of the Great Vessels with a Systemic Right Ventricle (RV)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
14
  53.8%
1.Primary Outcome
Title Procollagen N-terminal Peptide 1
Hide Description [Not Specified]
Time Frame Baseline, 6 months and 12 months from eplerenone administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome analyzed only during the eplerenone period as specified in the protocol
Arm/Group Title Total Study Group
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Change from baseline at time of drug initiation
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ug/ml
Baseline 45.1  (15.4)
6 Months 48.9  (20.3)
12 Months 42.7  (12.2)
2.Primary Outcome
Title Procollagen III N-Terminal Peptide
Hide Description [Not Specified]
Time Frame Baseline, 6 months and 12 months from eplerenone administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome analyzed only during the eplerenone period as specified in the protocol
Arm/Group Title Total Study Group
Hide Arm/Group Description:
Change from baseline at time of drug initiation
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ug/ml
Baseline 4.6  (1.7)
6 Months 4.4  (1.5)
12 Months 4.4  (1.5)
3.Primary Outcome
Title Galectin 3
Hide Description [Not Specified]
Time Frame Baseline, 6 months and 12 months from eplerenone administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome analyzed only during the eplerenone period as specified in the protocol
Arm/Group Title Total Study Group
Hide Arm/Group Description:
Change from baseline at time of drug initiation
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/ml
Baseline 10.0  (2.4)
6 Months 11.6  (2.9)
12 Months 11.2  (2.2)
4.Secondary Outcome
Title 6 Minute Walk
Hide Description [Not Specified]
Time Frame Baseline, 6 months, 12 months from eplerenone administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome analyzed only during the eplerenone period as specified in the protocol
Arm/Group Title Total Study Group
Hide Arm/Group Description:
Change from baseline at time of drug initiation
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: Feet
Baseline 1629  (261)
6 Months 1630  (250)
12 Months 1680.2  (255)
5.Secondary Outcome
Title Quality of Life
Hide Description Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function
Time Frame Baseline, 6 months, 12 months from eplerenone administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome analyzed only during the eplerenone period as specified in the protocol
Arm/Group Title Total Study Group
Hide Arm/Group Description:
Change from baseline at time of drug initiation
Overall Number of Participants Analyzed 17
Mean (Inter-Quartile Range)
Unit of Measure: Score on a scale
Baseline
87.5
(70 to 95)
6 Months
90
(75 to 97.5)
12 Months
85
(75 to 95)
6.Other Pre-specified Outcome
Title Serum Creatinine
Hide Description [Not Specified]
Time Frame Baseline, 6 months, 12 months from eplerenone administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome analyzed only during the eplerenone period as specified in the protocol
Arm/Group Title Total Study Group
Hide Arm/Group Description:
Change from baseline at time of drug initiation
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline 0.9  (0.2)
6 Months 0.9  (0.2)
12 Months 0.9  (0.2)
Time Frame During 12 months while on eplerenone
Adverse Event Reporting Description Adverse event data only collected during the eplerenone period
 
Arm/Group Title Eplerenone Period
Hide Arm/Group Description Change from baseline at time of drug initiation
All-Cause Mortality
Eplerenone Period
Affected / at Risk (%)
Total   0/26 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Eplerenone Period
Affected / at Risk (%) # Events
Total   0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eplerenone Period
Affected / at Risk (%) # Events
Total   6/26 (23.08%)    
Cardiac disorders   
chest pain *  1/26 (3.85%)  1
hypotension *  1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders   
Leg cramping *  1/26 (3.85%)  1
Nervous system disorders   
dizziness *  1/26 (3.85%)  1
Renal and urinary disorders   
hyperkalemia *  1/26 (3.85%)  1
Skin and subcutaneous tissue disorders   
edema *  2/26 (7.69%)  2
*
Indicates events were collected by non-systematic assessment
Incomplete study enrollment led to inadequate power to derive reliable conclusions.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ari Cedars
Organization: UT Southwestern
Phone: 3149224788
Responsible Party: Ari Cedars, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01971593     History of Changes
Other Study ID Numbers: WI170964
First Submitted: October 23, 2013
First Posted: October 29, 2013
Results First Submitted: January 25, 2018
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018